Catheter Research, Inc: Medical Device Recall in 2015 - (Recall #: Z-1481-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.

Product Classification:

Class II

Date Initiated: April 7, 2015

Date Posted: April 29, 2015

Recall Number: Z-1481-2015

Event ID: 70948

Reason for Recall:

HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.

Status: Terminated

Product Quantity: 880 units

Code Information:

Model Number/Catalogue/Product Number: TMI1160; 61-5205; TMI1198; KM61-5205; 61-3205; Lot codes: J436A, J436B, J436C, J436D; J437A, J437B, J437C, J437D; Exp. J436 (2017-03); J437 (2017-03)

Distribution Pattern:

Domestic: MN, CA, OH, IL, FL, MA, WI, VA Foreign: None DOD/VA: None

Voluntary or Mandated:

Voluntary: Firm initiated